Medical Safety Officer - Electrophysiology

Role Summary

The Medical Safety Officer (MSO) provides medical safety stewardship for Medical Device products, collaborating with Quality, Regulatory, Clinical, Medical Affairs, Epidemiology and Safety sciences to assess safety signals and manage patient risk across the product lifecycle. The MSO executes the Medical Safety Organization’s strategy, builds cross-functional relationships, and serves as a subject matter authority in the therapeutic area, with primary responsibilities in Electrophysiology, Cardiac Imaging, Structural Heart, and Reprocessing.

Responsibilities

• Assess product risk-benefit and provide medical input on risk management documentation, including safety surveillance plans, health hazard evaluations, clinical evaluation reports, and safety communications; review labeling and safety training materials to minimize patient risk.
• Clinically interpret post-marketing safety data, aggregate complaint data, individual case safety reports, and literature with potential safety data.
• Contribute to design and interpretation of safety-related studies and SSP activities.
• Represent Medical Safety in product reviews during development; evaluate medical impact of manufacturing and design issues.
• Oversee and guide performance and Medical Safety of products; monitor external sources for emerging issues (e.g., MDR/MDV trends, regulatory trends, literature).
• Advise on failure investigations and provide medical opinion on reportability; work with customers/users to gather medical information for investigations.
• Review safety-related information provided to customers to prevent repeated events; discuss AE investigations with healthcare professionals as requested.
• Act as medical representative in field action reviews and evaluate effectiveness of field safety actions.
• Ensure consistency of medical evaluations and safety assessments; deploy standard practices with MD CMO; use appropriate metrics to assess patient safety processes.
• Contribute to defining product harms and hazards lists and reportability criteria; act as SME in audits and regulatory interactions; review and approve medical safety reports and filings.
• Coordinate with Regional Safety Officers for timely information sharing.

Qualifications

• Required: Doctor of Medicine (MD), Doctor of Osteopathy (DO), or equivalent; minimum of 3 years clinical or research experience; relevant cardiovascular field experience; proficiency with Microsoft Office; knowledge of basic statistical techniques and epidemiological principles; knowledge of basic pre-clinical/clinical research concepts.
• Preferred: Specialties in Electrophysiology, Interventional Cardiology, Cardiology, or Interventional Radiology; experience in risk evaluation and mitigation; medical device/pharmaceutical industry experience; clinical study/research experience; experience working with senior leadership in a global company; advanced statistical knowledge; knowledge of local and international Medical Device regulations.